Safety Study of Tritanrix™-HepB/Hib-MenAC, Tritanrix™-HepB/Hiberix™, and Mencevax™ ACWY Vaccines in Children
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00228917
First received: September 27, 2005
Last updated: October 27, 2011
Last verified: October 2011
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Purpose
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax™ ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix™-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Meningococcal Infection Diphtheria Pertussis Haemophilus Infection Tetanus |
Biological: DTPw-HBV/Hib-MenAC-TT vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Assess Reactogenicity & Safety of a Booster of Either Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax™ ACWY at 24-30 Mths (Open Label) |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Fever
Hepatitis
Hepatitis A
Hepatitis B
Meningococcal Infections
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- D0-3: Fever >38.5°C (axillary).
Secondary Outcome Measures:
- D0-3: Solicited local & general symptoms (including fever other than >38.5°C). D0-30: unsol. symptoms. SAEs -full study period.
| Enrollment: | 798 |
| Study Start Date: | June 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: DTPw-HBV/Hib-MenAC-TT vaccine
Other Name: DTPw-HBV/Hib-MenAC-TT vaccine
Subjects previously primed with Tritanrix™-HepB/Hib-MenAC will receive Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ vaccine (at 15-18/24 m), respectively, without or with Mencevax™ ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix™-HepB/Hiberix™ will receive Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ vaccine (at 15-18/24 m) with Mencevax™ ACWY vaccine at 24 to 30 months of age.
Eligibility| Ages Eligible for Study: | 427 Days to 577 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228917
Locations
| Philippines | |
| GSK Investigational Site | |
| Muntinlupa, Philippines, 1781 | |
| Thailand | |
| GSK Investigational Site | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00228917 History of Changes |
| Other Study ID Numbers: | 103812, 104171 |
| Study First Received: | September 27, 2005 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by GlaxoSmithKline:
|
Hib & Neisseria meningitidis serogroups A & C diseases |
Additional relevant MeSH terms:
|
Diphtheria Haemophilus Infections Hepatitis Hepatitis A Hepatitis B Meningococcal Infections Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Neisseriaceae Infections Bordetella Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on May 22, 2013